Senior Data Manager – We offer an opportunity to learn, progress and achieve, in a dynamic growing environment.

We are a growing international full service CRO company with an HQ in Guildford UK and major sites across the globe that offers its employees a genuine opportunity to develop, varied and interesting challenges, and recognition for achievement,

The Company: Ergomed established in 1997 by two physicians in Croatia, provides expertise in drug development.   Since this beginning, the company has grown to employ 700 people worldwide including its division of PrimeVigilance and is listed on the LSE.   Our clients value us for our scientific and medical expertise and we have one of the highest client retention rates in the industry.

 

  • Our innovative site management and study physician model set us apart from our competitors.
  • Helping to develop drugs that improve patient’s lives is our passion

The Position: We are looking for a clinical data manager with programming skills (SQL/SAS) , to be based in to be based remotely from home or one of our global office locations.

 

  • We offer the chance to work in a growing Clinical data management   team working on a wide range of projects and therapy areas,  and across all phases
  • We offer a friendly professional working environment
  • We offer a competitive salary plus a good benefits package

Requirements:

  • Proven experience working within clinical data management and good technical skills (SQL/SAS)
  • Ability to project manage client relationships and ongoing data management projects
  • Experience of EDC systems and design of eCRF’s
  • Able to work in a fast paced environment and manage multiple projects
  • A minimum of a science based Bachelors degree

 

  • Brief summary of Responsibilities:
  • Provide oversight and coordination of all DM activities in a project.
  • Coordinate the Data Entry Clerks (DEC) and Database Developers (DBD) allocated to a project.
  • Development of Case Report Forms (CRFs) for data collection.
  • Creation, update and filing of project-related documentation (e.g. Data Management plan (DMP), Data Validation Plan (DVP), Data Entry Guideline, Database Specification Document (DBSD), Database Report (DBR)) in the DM TMF.
  • Performing and documenting periodic QC of DM TMF files and follow up on all action items until closure
  • Perform clinical database development, including data entry screen design, testing and validation based on the DBSD.
  • Program, test and validate edit checks.
  • Create the annotated CRF and other database-related documentation.
  • Combine external data with the clinical database in cooperation with the Statistical Programmer.
  • Perform initial coding of verbatim entries on adverse events, medical history and medications according to MedDRA and WHO-Drug dictionaries in the clinical database and forward to medical expert for quality control
  • Export data from the clinical database to authorized recipients (e.g. in CDISC SDTM format).
  • Generation of queries based on edit checks or errors and omissions identified during data entry and manual data review to resolve identified problems.
  • Provide material for Data Review Meeting (DRM) and participate in DRM if required.
  • Perform database lock and unlock procedures.
  • Provide validated data exports from the EDC system or the clinical database to authorized recipients (e.g. related to SAE Reconciliation and medical coding where applicable).
  • Communication with the sponsor in close cooperation with the PM.
  • Attend meetings with project team and/or client

 

The Location: Office or home based in the UK, Croatia, Serbia,  Poland or Germany.

 

Why Should You Apply?

  • You want be involved in a wide range of interesting projects and studies
  • You want your achievements  and hard work to be recognized
  • You want to work for a growing company where you can progress in your career and where there are opportunities for advancement.
  • You want to work in a company that has a great reputation with its clients and employees, and invests in its relationships with both.

If you would like to apply, please send your CV and cover letter to careers@ergomedplc.com